A Whipple procedure is a major operation often used to treat pancreatic cancer. After surgery, patients face an elevated risk of dangerous blood clots and are often sent home with daily injections to help prevent them. While effective, those injections can add another challenge during an already difficult recovery.
Seeing the challenges patients faced, Dr. Jason Heckman and colleagues at St. Peter’s Health Partners, a member of Trinity Health and one of the largest not-for-profit health systems in Albany, New York, set out to evaluate whether an oral medication could provide similar protection against blood clots while reducing the burden on patients recovering at home.
Research in other cancer specialties suggested oral blood thinners could be a promising alternative, but there were no randomized trials focused specifically on patients undergoing a Whipple procedure. The team initially set out to design a randomized clinical trial, but funding proved difficult to secure.
Using Truveta Data, the researchers found another way to answer the question.
A question rooted in patient care
For Heckman, a surgeon and the study’s principal investigator, the research began with a challenge he saw in clinical practice. Patients recovering from a Whipple procedure had already undergone a major operation, and some were uncomfortable giving themselves injections or relying on a family member to administer them.
“We’re always looking for ways to reduce burden on patients while maintaining high-quality care. Questions like this come directly from clinical practice. You see where patients struggle, and you start asking whether there’s a better path forward.” – Jason T. Heckman, MD, FACS, Medical Director, St. Peter’s Hepato-Pancreato-Biliary Institute, Research Division
Heckman became interested in oral blood thinners after reading research involving patients undergoing gynecologic cancer surgery. The findings suggested an oral medication could be an alternative to injections following surgery, but it was unclear whether those results would apply to patients undergoing a Whipple procedure.
The St. Peter’s team wanted to help fill that gap by comparing outcomes among patients who received enoxaparin, the standard injectable medication, and those who received apixaban, an oral blood thinner.
Expanding beyond locally available patients
The researchers began by looking at patients treated within their own health system. While the local analysis provided an initial view of the question, it included just 57 patients, illustrating one of the challenges of studying specialized procedures like Whipple surgery. Even large surgical centers may see relatively few eligible patients each year.
Using Truveta Data, the team was able to expand the study to nearly 900 patients across several Truveta member health systems. The larger population gave researchers the opportunity to evaluate the question at a scale that would not have been possible using local data alone.
For Damen Schaak, Clinical Research Manager at St. Peter’s Health Partners, the value extended beyond increasing the size of the dataset. The project also helped the team translate a clinical question into a real-world study and ensure they were analyzing the right patient population.
“The scale really opened the opportunity for a more robust study. Truveta gave us access to a much larger patient population, but it was also valuable to work with a team who helped us understand and structure the data. That allowed us to stay focused on the question we were actually trying to answer.” Damen Schaak, Clinical Research Specialist, St. Peter’s Health Partners Medical Associates
Working together, the teams refined the study design and identified the patients needed to answer the research question. The result was a larger, more comprehensive study of a challenge clinicians had first observed in everyday patient care.
Building evidence for future care pathways
The study has since been submitted for publication, marking an important milestone for a question that began with a challenge observed in routine care.
While randomized clinical trials remain the gold standard for evaluating treatments, they can be difficult to conduct for specialized procedures like Whipple surgery. By leveraging real-world data, the St. Peter’s team was able to generate evidence that may help inform future research and continue advancing the conversation around postoperative care.
“A randomized trial is still the ideal way to answer a question like this, but studies like ours can help build the evidence needed to move the field forward,” said Heckman. “When you have the ability to learn from a broader population of patients, it creates opportunities to ask and answer questions that would be difficult to study at a single institution.”
The experience also highlighted new possibilities for future research. Rather than relying on the experience of a single hospital, researchers can evaluate important clinical questions across a broader and more representative population of patients. For St. Peter’s Health Partners, what began as a question about reducing the burden of recovery became an opportunity to generate new evidence that may help improve care for future patients.
